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NCT Number: NCT04258540

The Effects of Yoga on Student Mental Health

The investigators performed a randomised controlled trial with 202 healthy university students in the Oslo area, with 50:50 in a yoga intervention group and a waitlist control group. Measures included symptoms of depression and anxiety, sleep problems, heart rate variability (HRV), well-being and mindfulness at week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

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Key information

Conditions

Mental Health Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Personal Satisfaction Psychological Well-Being Public Health Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Problem Sleep Wake Disorders University Students

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Norway

About this study

Universities around the world are facing an epidemic of mental health problems among their students. The problem is truly a public health issue, affecting many and with serious consequences. Moreover, the global burden of disease-agenda calls for effective interventions with lasting effects that have the potential to improve the mental health of young adults. In this study the investigators aimed to determine whether yoga, a popular and widely available mind-body practice, can improve student mental health.

The participants were randomly assigned to a yoga group or waitlist control group in a 1:1 ratio by a simple online randomisation program. The intervention group was offered 24 yoga sessions over 12 weeks. Measurements were taken at week 0 (baseline), week 12 (post-intervention), and week 24 (follow-up). The primary outcome was psychological distress assessed by the HSCL-25 questionnaire. Analysis was performed based on the intention to treat-principle.

The methods were laid out in a protocol, previously published on the website of the study. (available at http://yogastudy.tilda.ws/). The planned analyses were very straightforward and included a description of the study participants, and simple analyses of each of the a priori selected outcome measures. We have not included or excluded any variables post-hoc.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Living in the Oslo area

Exclusion criteria

  • No serious mental health diagnoses
  • No recent major life crisis
  • No systematic yoga practice during the prior six months

Treatment and study plan

Yoga group

Behavioral

The intervention group received yoga 2 times a week for 12 weeks (á 1.25 hr).

Other names: Intervention group

yoga course

Behavioral

yoga course

Primary outcomes

  1. Change in Psychological Distress

    Time frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)

    Measured with the Hopkins Symptom Checklist 25 (HSCL-25) questionnaire. Consists of 25 items on symptoms of depression and anxiety, each rated on a 1 (not at all) to 4 (very much) scale. Total scores range from 1 to 4, a higher score indicating more psychological distress.

Secondary outcomes

  1. Change in Heart Rate Variability (HRV)

    Time frame: Week 0 (baseline) and week 12 (post-intervention)

    Measured with nocturnal RMSSD (root mean square of successive differences), which is a validated measure of activity in the parasympathetic part of the autonomic nervous system. In general, an increase in RMSSD is associated with increased parasympathetic system activity and less distress.

  2. Change in Mental Well-being

    Time frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

    Measured with the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), a 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). This scale has five response categories (from "not at all" to "all the time") that are added together to produce a total score ranging from 14 to 70. Higher scores indicate higher levels of mental well-being.

  3. Change in Life Satisfaction

    Time frame: week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

    Measured with the Satisfaction With Life Scale (SWLS), a 5-item questionnaire. Items are scored on a 1- to 7-point Likert scale. The total score is computed by adding all response values (ranging from 5 to 35), with higher scores indicating higher satisfaction.

  4. Change in Mindfulness

    Time frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

    Mindful Attention Awareness Scale, MAAS, a 15-item scale. The total score was computed by adding the score value on all individual items, producing a total score ranging from 15 to 75, with higher scores indicating higher levels of mindfulness.

  5. Change in Sleep Problems

    Time frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

    The investigators used the Bergen Insomnia Scale (BIS), a 6-item scale. Scores from 0 (no bad nights during the course of a week) to 7 (all nights) give a total score ranging from 0 to 42 (higher scores indicating more troubled sleep and daytime tiredness).

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

The Effects of Yoga on Student Mental Health: A Randomised Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2020
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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